In an article on the front of its business section, the New York Times(2/22, B1, Meier, Subscription Publication) reports that, in contrast to Johnson & Johnson’s statements prior to its recall of an all-metal artificial hip that “it was safe and maintained that its internal studies refuted complaints by surgeons and regulators abroad that the device was flawed.” An internal email by an executive a year before the recall said the FDA “refused to approve the device, after reviewing company studies that showed it had failed prematurely in ‘significant’ numbers requiring repeat surgeries.”

The FDA “as a matter of policy, does not release such decisions,” saying, “that they may contain confidential business information.”

Johnson & Johnson subsidiary, DePuy Orthopaedics’s “decision not to publicize the agency’s findings to doctors, patients and others while continuing to market the device may undercut its defense in the 5,000 related lawsuits pending against it and could also tarnish its reputation.”

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